Pronunciation:

floo-TIK-a-sone

Brand Names:

• Flonase
• Veramyst
• Xhance

Dosage Forms:

• Spray

Classifications:

Therapeutic—

Corticosteroid, Intermediate

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Fluticasone nasal spray is used to treat sneezing, itchy or runny nose, or other symptoms caused by hay fever. It is also used to treat chronic rhinosinusitis with or without nasal polyps (CRSwNP) in adults. This medicine belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing certain cells from releasing substances that cause an allergic reaction.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluticasone nasal spray in children. However, safety and efficacy of Veramyst® nasal spray have not been established in children younger than 2 years of age, and fluticasone propionate nasal spray in children younger than 4 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of Xhance® nasal spray in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone nasal spray in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving fluticasone nasal spray.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin
• Levoketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Amphetamine
• Aspirin
• Atazanavir
• Bemiparin
• Boceprevir
• Bupropion
• Carbamazepine
• Ceritinib
• Clarithromycin
• Cobicistat
• Conivaptan
• Cosyntropin
• Dabrafenib
• Darunavir
• Dasabuvir
• Dextroamphetamine
• Duvelisib
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Idelalisib
• Indinavir
• Itraconazole
• Ivosidenib
• Josamycin
• Ketoconazole
• Larotrectinib
• Lefamulin
• Lenacapavir
• Lisdexamfetamine
• Lonafarnib
• Lopinavir
• Lorlatinib
• Lumacaftor
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Mibefradil
• Mifepristone
• Nadroparin
• Nefazodone
• Nelfinavir
• Netupitant
• Nirmatrelvir
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Phenobarbital
• Pirtobrutinib
• Posaconazole
• Primidone
• Ribociclib
• Ritlecitinib
• Ritonavir
• Saquinavir
• Sargramostim
• Somatrogon-ghla
• Telaprevir
• Telithromycin
• Tipranavir
• Trofinetide
• Troleandomycin
• Tucatinib
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Cataracts, history of or
• Glaucoma, history of or
• Osteoporosis, family history of—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Measles or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, or fungus), any type of or
• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.

• Injury to the nose, recent or
• Nose surgery, recent or
• Sores in the nose, recent—This medicine may prevent proper healing of these conditions.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.

To use the fluticasone propionate and Veramyst® nasal spray:

• When you use the fluticasone nasal spray for the first time, you must prime the spray. Press down fully the top of the pump 6 times or until a fine spray comes out. Prime the spray if it has not been used for more than 7 days (fluticasone propionate) or 30 days (Veramyst®) or if the cap has been left off the bottle for 5 days or longer. Shake the medicine well before each use.
• Gently blow your nose before using the spray. Tilt your head back slightly and insert the tip of the nose piece into your nostril.
• Close the opposite nostril with a finger. Release 1 spray and at the same time, breathe in gently through the nostril.
• Hold your breath for a few seconds then breathe out slowly through your mouth.
• Spray the opposite nostril using the same steps.
• Do not blow your nose or tip your head back after using the spray.
• Wipe the tip of the outside of the nose piece with a clean, dry tissue or cloth and put the cap back on.
• Throw this medicine away after you use 120 sprays.

To use the Xhance® nasal spray:

• Shake the medicine well before each use.
• When you use this medicine for the first time, you must prime the spray. To do this, pump the bottle 7 times into the air away from the face, or until some medicine comes out. If you have not used this medicine for 7 days or longer, prime it again by shaking and spraying 2 times.
• Insert the tip of the cone-shaped nosepiece deep into the nose to create a seal between the nosepiece and the nostril.
• Place the mouthpiece inside your mouth and blow on it. While blowing, push the bottle up to actuate the spray pump.
• Continue to blow through your mouth until the medicine is released, but do not inhale or exhale through the nose.
• Repeat in the other nostril for a full dose.

You may need to use this medicine for a few days before you start to feel better.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For chronic rhinosinusitis with or without nasal polyps (CRSwNP):
  • For nasal dosage form (spray):
    • Xhance®:
      • Adults—At first, 1 or 2 sprays in each nostril 2 times a day. Each spray contains 93 micrograms (mcg) fluticasone. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
• For symptoms of hay fever:
  • For nasal dosage form (spray):
    • Fluticasone propionate:
      • Adults—At first, 2 sprays in each nostril once a day. Some patients may need 1 spray in each nostril 2 times a day (morning and evening). Your doctor may adjust your dose as needed.
      • Children 4 years of age and older—At first, 1 spray in each nostril once a day. Some patients may need 200 mcg or 2 sprays in each nostril once a day.
      • Children younger than 4 years of age—Use is not recommended.
    • Veramyst®:
      • Adults and children 12 years of age and older—At first, 2 sprays in each nostril once a day. Your doctor may decrease your dose to 55 mcg or 1 spray in each nostril once a day.
      • Children 2 to 11 years of age—At first, 1 spray in each nostril once a day. Your child's doctor may need to increase the dose up to 2 sprays in each nostril once a day depending on your child's condition.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw this medicine away after you have used 120 sprays.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

This medicine may cause holes or ulcers in the cartilage of the nose and delay wound healing. Make sure your doctor knows if you have had nose surgery, a nose injury, or an infection in your nose in the last few months before using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

You may get infections more easily while using this medicine. Tell your doctor right away if you have been exposed to someone with chickenpox or measles. Also tell your doctor if you develop white patches or sores in your nose while you are using this medicine. This could be symptoms of a candida or yeast infection.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. Talk with your doctor if you have concerns about this.

This medicine may slow down a child's growth. If you think your child is not growing properly while using this medicine, talk with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloody nose

chest tightness

cough

fever

headache

muscle aches

pain or tenderness around the eyes and cheekbones

sore throat

stuffy or runny nose

trouble breathing

unusual tiredness or weakness

Less common

Blurred vision

change in vision

loss of vision

Incidence not known

Difficulty with swallowing

dizziness

fast heartbeat

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

skin rash, itching, hives or welts

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Back pain

dizziness

pain in the mouth and nose

stomach discomfort

toothache

weight increased

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.